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July/August 2008
UpDate

Newly Approved Nanotech
Standards to Aid in Cancer Research

The battle against cancer is being fought on many fronts. Among the most cutting-edge research efforts are the standards being developed by the Nanotechnology Characterization Laboratory, part of the National Cancer Institute’s Alliance for Nanotechnology in Cancer. Committee E56 on Nanotechnology has recently approved three NCL standards, whose use could pave the way for commercially available nano-scale cancer drugs, as ASTM International standards. The new standards are under the jurisdiction of Subcommittee E56.02 on Characterization: Physical, Chemical and Toxicological Properties.

The new standards, all of which evaluate aspects of nanomaterial biocompatibility and toxicity, are:

E2524, Test Method for Analysis of Hemolytic Properties of Nanoparticles. E2524 is a protocol for examining the destruction of red blood cells (hemolysis) that can lead to anemia, jaundice and other issues. All intravenously administered drugs must be examined to determine potential for hemolysis.

E2525, Test Method for Evaluation of the Effect of Nanoparticulate Materials on the Formation of Mouse Granulocyte-Macrophage Colonies. E2525 describes a method for evaluating nanoparticle stimulation or inhibition of certain bone marrow cells, or macrophages. A common side effect of anti-cancer drugs is inhibition of bone marrow cells, and they may be particularly sensitive to nano-scale material.

E2526, Test Method for Evaluation of Cytotoxicity of Nanoparticulate Materials in Porcine Kidney Cells and Human Hepatocarcinoma Cells. Because studies have indicated that many nanoparticles are cleared from the body through the kidney or liver, these organs are good choices for target organ toxicity evaluation. E2526 presents a method for evaluation of nanomaterial toxicity by examining effects on kidney and cancerous liver cells.

According to Martin Fritts, senior principal scientist, Nanotechnology Characterization Laboratory, and co-chair, Subcommittee E56.02, nanotech drug developers, scientists in the pharmaceutical, cancer research and nanotechnology fields, regulatory agencies and agencies evaluating the environmental health and safety risks associated with nanoparticles will all be users of the new standards.

“We expect that standardization will accelerate the translation of nanotech therapeutics from the proof-of-concept discovery phase into clinical trials and eventually into commercially available drugs and benefits to patients,” says Fritts, who notes that nanoparticle developers and manufacturers have used ASTM standards in the medical and pharmaceutical fields but that the unique properties of nanomaterials frequently limit the applicability of more traditional pharmaceutical methods.

Fritts says that Subcommittee E56.02 is planning on the development of other proposed standards as well as revisions that will incorporate precision and bias statements into the recently approved standards. To accomplish this, E2524, E2525 and E2526 are now being used in an ASTM-sponsored interlaboratory study involving more than 100 labs. The subcommittee is seeking assistance with data analysis for the study as well as participants for future studies. “Such interlaboratory comparison and standards for nanoparticle characterization will help alleviate confusion, dispel ambiguity and speed the regulatory process and the translation for nanotech drugs from discovery to development,” says Fritts.

Fritts also notes that the interlaboratory study will include a variety of nanoparticles, including the first reference standards developed by NIST specifically for nano-scale particles targeted for the biomedical research community. These new reference materials, which were produced with support from the NCI Alliance for Nanotechnology in Cancer and the NCL, consist of colloidal gold nanoparticles with nominal diameters of 10, 30 and 60 nanometers in suspension. The new reference materials are intended for instrument calibration, method qualification and in vitro experiments used to characterize nanomaterials.

CONTACT

Technical Information: Martin Fritts, Nanotechnology Characterization Center, Frederick, Md.

Phone: 301-846-6938

ASTM Staff: Pat Picariello

Phone: 610-832-9720